Devices

COBAS INTEGRA 800 Analyzer

Model / Serial
software version 9864.C2
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution and Puerto Rico
Product Description
COBAS INTEGRA 800 Analyzer with software 9864.C2 || Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory || A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of COBAS INTEGRA 800 Analyzer

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

One device with a similar name

Learn more about the data here

cobas c-pack MULTI for cobas c 311/501/502 analyzer, COBAS INTEGRA 400/400 plus, COBAS INTEGRA 80...

Model / Serial
Product Description
IVD: Clinical chemistry analyser
Manufacturer
Roche Diagnostics GmbH

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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